| ZOLL Stat-padz II Electrodes and ZOLL Pedi-padz II Electrodes (P160015/S008) | ZOLL Medical Corporation | 2020-12-30 |
| Infuse Bone Graft (P000054/S061) | Medtronic Sofamor Danek USA, Inc. | 2020-12-30 |
| OPTIMIZER Smart System (2-Lead configuration) (P180036/S006) | Impulse Dynamics (Usa), Inc. | 2020-12-30 |
| Nucleus Auditory Brainstem Implant System (P000015/S044) | Cochlear Americas | 2020-12-30 |
| Tula System (P190016/S002) | Tusker Medical, Inc. | 2020-12-30 |
| 24 Cochlear Implant System (P970051/S200) | Cochlear Americas | 2020-12-30 |
| ZOLL CPR Uni-padz (P160015/S009) | ZOLL Medical Corporation | 2020-12-30 |
| Hybrid Implant System (P130016/S044) | Cochlear Americas | 2020-12-30 |
| Prometra Programmable Infusion Pump System (P080012/S056) | Infusyn Therapeutics, LLC | 2020-12-30 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S080) | Medtronic Sofamor Danek USA, Inc. | 2020-12-30 |
| TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del (P980040/S117) | Johnson & Johnson Surgical Vision, Inc. | 2020-12-29 |
| Vercise Deep Brain Stimulation (DBS) System (P150031/S028) | Boston Scientific Corp | 2020-12-29 |
| GELSYN-3 (P110005/S007) | Ibsa Institut Biochimique SA | 2020-12-28 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S479) | Medtronic Neuromodulation | 2020-12-23 |
| Floseal Hemostatic Matrix (P990009/S065) | Baxter Healthcare Corp | 2020-12-23 |
| Spiration® Valve System (SVS) (P180007/S007) | Gyrus Acmi, Inc. | 2020-12-23 |
| RF Conductr, RF Contactr, RF Marinr, RF Marinr Unipolar, and RF Enhancr II (P930029/S069) | Medtronic, Inc. | 2020-12-23 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S037) | Cook Ireland, Ltd. | 2020-12-22 |
| SURGICEL Absorbable Hemostat (N12159/S077) | ETHICON, Inc. | 2020-12-22 |
| HiResolution Bionic Ear System (P960058/S151) | Advanced Bionics | 2020-12-22 |
| WaveLight Allegretto Wave Excimer Laser System (P020050/S036) | Alcon Laboratories, Inc. | 2020-12-22 |
| Belotero Balance Dermal Filler, Belotero Balance + Lidocaine Dermal Filler (P090016/S042) | Merz North America, Inc. | 2020-12-22 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (P130024/S037) | Lutonix | 2020-12-22 |
| CardioMEMS HF System (P100045/S046) | ABBOTT MEDICAL | 2020-12-22 |
| LIPOSORBER LA-15 System (P910018/S028) | Kaneka Pharma America Corp. | 2020-12-22 |
| WaveLight Allegretto Wave Excimer Laser System (P030008/S032) | Alcon Laboratories, Inc. | 2020-12-22 |
| CapSureFix MRI Lead (P090013/S313) | Medtronic, Inc. | 2020-12-22 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S667) | Medtronic, Inc. | 2020-12-22 |
| AngelMed Guardian System (P150009/S004) | Avertix Medical, Inc. | 2020-12-22 |
| Spectranetics CVX-300 Excimer Laser System (P910001/S111) | Spectranetics Corp. | 2020-12-22 |
| CapSureFix Novus Lead (P930039/S220) | Medtronic, Inc. | 2020-12-22 |
| CapSure Sense Lead (P830061/S189) | Medtronic Cardiac Rhythm Disease Management | 2020-12-22 |
| Gore Excluder Conformable AAA Endoprosthesis (CEXC) (P200030) | W. L. Gore and Associates, Inc. | 2020-12-22 |
| enVista One-Piece Foldable Acrylic Intraocular Lens (P910056/S044) | Bausch & Lomb, Inc. | 2020-12-21 |
| Restylane Kysse Injectable Gel (P140029/S029) | Q-Med AB | 2020-12-21 |
| Zoll AED 3 (P160015/S007) | ZOLL Medical Corporation | 2020-12-21 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S031) | Medinol, Ltd. | 2020-12-21 |
| LCS Total Knee System (P830055/S261) | Depuy, Inc. | 2020-12-21 |
| Tridyne Vascular Sealant (P150016/S018) | Neomend, Inc. | 2020-12-21 |
| Pipeline Flex Embolization Device (P100018/S030) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-12-21 |
| Progel Pleural Air Leak Sealant (P010047/S062) | Neomend, Inc. | 2020-12-21 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S040) | Medtronic Vascular | 2020-12-21 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S105) | Medtronic Vascular | 2020-12-21 |
| MemoryGel Xtra Silicone Gel-Filled Breast Implant (P030053/S056) | Mentor Corp. | 2020-12-21 |
| Radiesse Injectable Implant and Radiesse (+) Lidocaine Dermal Filler (P050052/S116) | Merz North America, Inc. | 2020-12-21 |
| Radiesse Injectable Implant (P050037/S099) | Merz North America, Inc. | 2020-12-21 |
| HeartWare HVAD System (P100047/S169) | Medtronic | 2020-12-21 |
| Akreos One-Piece Foldable Acrylic Intraocular Lens (P060022/S028) | Bausch & Lomb, Inc. | 2020-12-21 |
| NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System (P060037/S069) | Zimmer, Inc. | 2020-12-21 |
| Phylax AV ICD System (P000009/S089) | Biotronik, Inc. | 2020-12-18 |
| SCULPTRA and SCULPTRA Aesthetic (injectable poly-L Lactic acid) (P030050/S033) | Q-Med AB | 2020-12-18 |
| Siello S 45 leads and Solia S 45 leads (P950037/S215) | Biotronik, Inc. | 2020-12-18 |
| InterStim Therapy System, Verify Evaluation System, and InterStim Micro Implantable Neurostimulator (SNS Urinary) (P970004/S325) | Medtronic Neuromodulation | 2020-12-18 |
| DEFLUX Injectable Gel (P000029/S093) | Palette Life Sciences | 2020-12-18 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S477) | Medtronic Neuromodulation | 2020-12-18 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S727) | Medtronic Cardiac Rhythm Disease Management | 2020-12-18 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S121) | Biotronik, Inc. | 2020-12-18 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 (P950037/S218) | Biotronik, Inc. | 2020-12-18 |
| InterStim Therapy System, Verify Evaluation System, and InterStim Micro Implantable Neurostimulator (SNS Bowel) (P080025/S220) | Medtronic Neuromodulation | 2020-12-18 |
| Solesta Injectable Gel (P100014/S030) | Palette Life Sciences | 2020-12-18 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- (P980023/S104) | Biotronik, Inc. | 2020-12-18 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S665) | Medtronic, Inc. | 2020-12-18 |
| GORE CARDIOFORM ASD Occluder (P050006/S086) | W. L. Gore & Associates, Inc. | 2020-12-18 |
| Edwards Commander Delivery System (P200015/S007) | Edwards Lifesciences, LLC | 2020-12-18 |
| Tupos LV/ATX & Kronos LV-T CRT-D and Corox OWT Steroid LV Pacing Lead (P050023/S151) | Biotronik, Inc. | 2020-12-18 |
| Edora 8 CRT-P, Evity 8 CRT-P, and Enitra 8 CRT-P and Corox OTW, Sentus (ProMRI) OTW Drug Eluting Permanent Left Ventricu (P070008/S118) | Biotronik, Inc. | 2020-12-18 |
| Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter (P150005/S058) | Boston Scientific Corp | 2020-12-18 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S366) | Medtronic, Inc. | 2020-12-18 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S067) | St Jude Medical | 2020-12-18 |
| Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( (P050023/S153) | Biotronik, Inc. | 2020-12-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev (P980016/S766) | Medtronic Cardiac Rhythm Disease Management | 2020-12-18 |
| Activa Deep Brain Stimulation Therapy System and Percept PC BrainSense Implantable Neurostimulator (P960009/S390) | Medtronic, Inc. | 2020-12-18 |
| Implantable System for Remodulin (P140032/S064) | Medtronic, Inc. | 2020-12-18 |
| OPRA Implant System (P190009) | Integrum AB | 2020-12-18 |
| Hydro Thermablator Endometrial Ablation System (P000040/S040) | Axora Medical, Inc. | 2020-12-17 |
| Resure Sealant (P130004/S010) | Ocular Therapeutix, Inc. | 2020-12-17 |
| 700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis (N970012/S184) | Boston Scientific Corp | 2020-12-17 |
| TREO Abdominal Stent-Graft System (P190015/S008) | Bolton Medical, Inc. | 2020-12-17 |
| Intellis Spinal Cord Stimulation Systems (P840001/S478) | Medtronic Neuromodulation | 2020-12-17 |
| Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar CRT-P (P010015/S460) | Medtronic, Inc. | 2020-12-17 |
| HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (P160054/S031) | ABBOTT MEDICAL | 2020-12-17 |
| Epic Vascular Self-Expanding Stent System (P110035/S064) | Boston Scientific Corp | 2020-12-17 |
| AMS 800 Artificial Urinary Sphincter (P000053/S119) | Boston Scientific Corp | 2020-12-17 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S066) | Boston Scientific Corporation | 2020-12-17 |
| NexGen LPS-Flex/LPS-Mobile Bearing Knee (P060037/S070) | Zimmer, Inc. | 2020-12-17 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S040) | Boston Scientific Corp | 2020-12-17 |
| PMMA Single-Piece Anterior Chamber Intraocular Lens (P880087/S030) | Alcon Laboratories | 2020-12-17 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S040) | Boston Scientific Corp | 2020-12-17 |
| Protecta ICD, Protecta VR ICD, and Protecta XT ICD (P980016/S759) | Medtronic Cardiac Rhythm Disease Management | 2020-12-17 |
| PMMA Single-Piece Posterior Chamber Intraocular Lens (P840060/S048) | Alcon Laboratories | 2020-12-17 |
| Bulkamid Urethral Bulking System (P170023/S007) | Boston Scientific Corporation | 2020-12-17 |
| Protecta CRT-D and Protecta XT CRT-D (P010031/S720) | Medtronic Cardiac Rhythm Disease Management | 2020-12-17 |
| AngioJet Thrombectomy Catheter (P980037/S084) | Boston Scientific Corp | 2020-12-17 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S025) | Bolton Medical, Inc. | 2020-12-17 |
| AcrySof Posterior Chamber Intraocular Lens (P930014/S134) | Alcon Laboratories, Inc. | 2020-12-17 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (P040020/S097) | Alcon Research, Ltd. | 2020-12-17 |
| Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear (P040029/S015) | Euclid Vision Corporation | 2020-12-17 |
| InterStim Therapy System and Verify Evaluation System (P080025/S221) | Medtronic Neuromodulation | 2020-12-16 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S763) | Medtronic Cardiac Rhythm Disease Management | 2020-12-16 |
| Hancock II Bioprosthesis (P980043/S075) | Medtronic, Inc. | 2020-12-16 |